The present invention relates to a prosthetic implant for obturating an anatomical duct, cavity or orifice and will be more particularly described by way of example for use in the treatment of hernias of the groin.
Various prosthetic implants for obturating hernial orifices are known in the prior art in the form of textile elements, strips or rectangles, wound in order to form either a cylinder or a cone. Such elements are then inserted in the orifice to be obturated. A certain number of technical solutions have been described, in particular in the documents U.S. Pat. No. 5,356,432, U.S. Pat. No. 5,116,357, U.S. Pat. No. 5,147,374 and U.S. Pat. No. 5,456,720. They all have in common the preforming, for example by thermoforming, of these cones or cylinders.
For example, according to FIG. 17 of the document EP-A-0544485, a prosthetic implant for obturating an anatomical duct, cavity or orifice is described as comprising a one-piece porous textile element obtained from a prosthetic fabric.
In a flat and nongathered-up configuration, this porous element has the shape of a textile patch with a continuous outer edge or periphery. It comprises several reinforcing radial elements, interlaced in the textile patch, extending and distributed around a central zone free from any said element. These reinforcing elements determine, by local thrust in said central zone, whilst centripetally stressing the remaining periphery of the textile element, a configuration gathered up in volume.
However, these prior solutions have several problems related to this preforming, particularly because the prosthetic implants which result from it are often too rigid. This results in the following disadvantages:
the obturating prosthetic implant is traumatizing or perforating with regard to the peritoneal structures and can adapt only with difficulty to the thickness of the abdominal wall;
the cone or cylinder shapes of the prosthetic implant do not favor its congruence with the complex geometry of a hernial orifice;
obturating prosthetic implants are subject to a lot of contact with the surgeon""s hands, thus increasing the risk of post operative infection;
traditional preformed obturating prosthetic implants do not allow the surgeon to reach sites not accessible with a finger.
The subject of the present invention is a prosthetic implant, as described above, having practically no privileged or residual shape, and therefore retaining good conformability, whilst nevertheless offering a certain rigidity during its manipulation, on the one hand in order to be inserted in gathered-up form into the anatomical orifice to be obturated and, on the other hand, to press in this form against the edge or the wall of said orifice, all of this in a non-traumatizing or hardly traumatizing manner.
A prosthetic implant according to the present invention combines the following characteristics:
it is in the textile element that are included and located without break, both the central zone free of any radial element and the peripheral zone which comprises these radial elements; the central zone is therefore filled by the textile element itself, and is not therefore occupied by another element or piece, in particular an added one.
the textile element will comprise at least two panels of superimposed prosthetic fabric;
and the two radial elements are shaped like two textile strips respectively, each consisting of a multiplicity of stitches linking, particularly by sewing or knitting, said two panels, with at least one thread.
Preferably, but not exclusively, in the gathered-up configuration, the two radial elements determine at least two opposite hollow, open or closed lobes formed by the two panels between said radial elements. This lobed configuration favors consistency of the textile element in its gathered-up configuration.
The present invention also relates to an obturating assembly comprising a prosthetic implant such as described above, and an applicator.
In effect, it has been found that a prosthetic implant according to the invention would exhibit the advantage that not preforming the implant in the shape of a cylinder or cone would favor its congruence with the complex geometry of an anatomical orifice, duct or cavity, for example hernial.
Preferably, the radial elements each extend radially from the outer edge of the textile element to an intermediate point between a geometric center of said textile element and the outer edge of said textile element.
More preferably, the radial elements each extend radially up to the central zone.
In preferred embodiment, the radial elements each extend radially over a limited length, starting from and in the vicinity of the outer edge.
Preferably, the two panels are connected to each other by discontinuous overstitching along the outer edges of the panels, in such a way as to determine open lobes in the gathered-up configuration of the implant.
According to a preferred embodiment, the two panels are connected to each other by the radial elements tying the two panels.
In another preferred embodiment, the textile element comprises at least three panels bound to each other, of identical or different nature, one of the panels possibly having a three-dimensional structure.
In a preferred way, the textile element is capable of being obtained by cutting out a circular patch bringing together an outer panel, an intermediate panel and an inner panel, by folding said patch along a diameter with two sides facing each other, radial elements connecting the three panels together, and at least two elements connecting the two sides facing each other of the inner panel.
Still more preferably, the radial elements connect two panels to each other, the third panel being connected to the other two by overstitching its outer edge.
In a preferred embodiment, the implant, the implant comprises an additional covering panel, bound to the textile element, having a shape different from that of the latter and adapted with an appropriate slit for surrounding any anatomical duct.